Biopsy device with aperture orientation and improved tip

ABSTRACT

The invention is directed to a system and device for separating and collecting a tissue specimen from a target site within a patient. The device includes a probe component which is releasably secured to the driver component. The probe component has an elongated tubular section, a penetrating distal tip and a tissue receiving aperture in the distal end of the tubular section proximal to the distal tip, and a tissue cutting member which is slidably disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture by applying a vacuum to the inner lumen of the tissue cutting member. The driver has drive members for operating the elements of the probe component. The tissue penetrating distal tip preferably has a triple concave curvature shape with three curved cutting edges leading to a sharp distal point.

RELATED APPLICATIONS

This application is a divisional of application Ser. No. 11/014,413,filed Dec. 16, 2004 which is incorporated herein in its entirety andfrom which priority is claimed.

FIELD OF THE INVENTION

Thee present invention relates generally to tissue removing devices suchas biopsy devices and the methods of using such devices. Morespecifically, it is directed to an improved device and method foraccessing and removing pathologically suspect tissue from within apatient's body.

BACKGROUND OF THE INVENTION

In diagnosing and treating certain medical conditions, such aspotentially cancerous tumors, it is usually desirable to perform abiopsy, in which a specimen of the suspicious tissue is removed forpathological examination and analysis. In many instances, the suspicioustissue is located in a subcutaneous site, such as inside a human breast.To minimize surgical intrusion into the patient's body, it is desirableto be able to insert a small instrument into the patient's body toaccess the targeted site and to extract the biopsy specimen therefrom.

Electrosurgical techniques have been used in a variety of biopsyprocedures. In electrosurgery, high frequency electrical energy istypically applied to patient tissue through an active electrode, theelectrical circuit being completed by a return electrode in contact withthe patent's tissue. Electrical energy flowing through the tissue fromthe active electrode is effective to ablate tissue near the activeelectrode, forming an opening in the tissue and so allowing insertion ofthe instrument into a patient's body. A return electrode may be placedon the exterior of the patient's body or may be incorporated into thedevice itself. The return electrode is typically attached to the patientat a point remote from where the primary or active electrode contactsthe tissue. However, in the case of a bipolar electrode for example, thereturn electrode may be disposed near to the active electrode. Anelectrosurgical biopsy instrument is disclosed and claimed in U.S.patent application Ser. No. 09/159,467 for “Electrosurgical BiopsyDevice and Method,” now U.S. Pat. No. 6,261,241, assigned to theassignee of the present application, and which is hereby incorporated byreference in its entirety. A variety of needle like tip designs havebeen developed to aid in the accessing of intracorporeal sites forbiopsy and other procedures. Electrosurgical techniques have also beenused in a variety of biopsy procedures to gain access to anintracorporeal site. See for example U.S. Pat. No. 6,261,241, assignedto the assignee of the present application, and which is herebyincorporated by reference in its entirety.

The prior needle like tips do not always allow proper placement of thebiopsy or other surgical device. Moreover, while the electrosurgicalbiopsy devices have been found to be effective in many instances, theyare not suitable for use in conjunction with magnetic resonance imaging.

While these electrosurgical biopsy devices have been found to beeffective in many instances, they may not always be suitable for use inconjunction with magnetic resonance imaging.

SUMMARY OF THE INVENTION

This invention is directed to devices for accessing and severing tissuefrom a target site within a patient and methods for utilizing suchdevices. The devices embodying features of the invention provide accessto a targeted tissue site within a patient and provide for theselection, separation and capture of a tissue specimen from supportingtissue at the targeted site.

A tissue accessing and severing device and system having features of theinvention generally include an elongated, preferably disposable probecomponent having a plurality of operative elements and a drivercomponent configured to receive the elongated probe component and drivethe various operative elements of the probe component.

The elongated probe component has a distal shaft portion with a tissuepenetrating distal tip, a tubular section proximal to the distal tip, aninner lumen extending within the tubular section and an open, tissuereceiving aperture in the tubular section which provides access totissue at the targeted site. The probe component includes an elongatedtissue-cutting member, which is preferably at least in partcylindrically shaped. The tissue cutting member is provided with atleast one tissue cutting edge which is configured to sever tissueextending into the interior of the tubular section through the aperturethereof. The cutting edge on the tissue cutting member may be configuredfor longitudinal cutting movement and may include oscillating rotationalmotion and/or reciprocating longitudinal motion to sever specimen tissueextending through the aperture from supporting tissue at the targetedsite. The cutting surfaces or edges are radially spaced from alongitudinal axis of the probe component and are generally transverselyoriented with respect to the longitudinal axis. The tissue cutter ispreferably slidably disposed within the inner lumen of the tubularsection, although it may be disposed about the tubular section. Theprobe component may also have a handle which releasably engages thedriver component.

In one embodiment of the invention, the cutting member has an innerlumen preferably extending to the proximal end thereof for tissuespecimen removal. While mechanical withdrawal of the tissue specimen maybe employed, it is preferred to provide a vacuum within the cuttingmember from the proximal end of the cutting member. The proximal end ofthe cutting member may be configured to be in fluid communication with avacuum source to aspirate the severed tissue specimen through the innerlumen of the cutting member to a tissue collection station. A higherfluid pressure may be maintained in the inner lumen of the cuttingmember distal to the tissue specimen to aid in transporting the specimenproximally through the inner lumen. In this manner, the mechanicalwithdrawal and/or the vacuum on the proximal end of the specimen and ahigher pressure on the distal end of the specimen can move the specimenthrough the inner lumen of the cutting member to a tissue collectionstation.

In at least one embodiment, the handle of the probe component issecured, preferably releasably secured, to the driver housing providedto operably connect the various operative elements of the probe withoperative elements of the driver component. The tissue cutting member isoperatively connected to at least one driver to provide the desiredcutting motion. The proximal end of the tubular section is rotatablysecured within the handle housing so that the orientation thereof withrespect to the longitudinal axis and therefore the orientation of thetissue receiving aperture within the tubular section, can be selected.The orientation of the aperture may be selected manually such asdescribed in copending application Ser. No. 10/642,406, filed Feb. Aug.15, 2003 or it may be preset or selected electronically by a controlmodule which also controls the operation of the cutting member andelectrical power. The aperture orientation setting may be selectedbefore or after the distal portion of the probe component is insertedinto the patient.

The tissue penetrating distal tip embodying features of the inventionhas a proximal base secured to the distal end of the probe shaft of thebiopsy device, and a sharp distal point distal to the proximal base. Thetissue penetrating distal tip has a first concave surface extending fromthe base to the sharp distal point. The distal tip also has a secondconcave surface, which intersects the first concave surface formingtherewith a first curved cutting edge that leads to the sharp distalpoint. The distal tip also has a third concave surface which intersectsthe first concave surface forming therewith a second curved cutting edgeleading to the sharp distal point and also intersects the second concavesurface forming therewith a third curved cutting edge that leads to thesharp distal point. The concave surfaces preferably have center lineswhich extend from the proximal base of the distal tip to the sharpdistal point. In a presently preferred embodiment the concave surfacesare of the same area. However, they may have different areas.

The driver component has at least two and preferably three driver unitsfor operating the probe component secured to the driver component.Specifically, the driver component has a first driver unit for rotatingthe tubular section of the probe component, a second driver unit formoving the cutting member along a longitudinal axis of the cuttingmember and optionally a third driving unit for rotating or oscillatingthe cutting member about the longitudinal axis. The first driver unitrotates the tubular section of the probe component, preferably indiscrete steps, so that the location of the tissue receiving aperture inthe distal extremity of the tubular section can be selected prior to orduring the procedure. The discrete rotational steps of the tubularsection are preferably in 30° or multiples thereof so that therotational movement will follow 12 hour clock markings. Preferably, thesecond and third driver units are operable together so that the cuttingmember may rotate or oscillate about a longitudinal axis as the cuttermember is moved longitudinally. This allows a rotation or an oscillationof the cutter during the cutting process which can aid in cuttingtissue.

The driver component may have one or more light sources in a distalportion thereof to illuminate the accessing site during the procedure.

A method of cutting and collecting a tissue specimen with a tissuecollection device embodying features of the invention includes advancingsuch a device at least partially into tissue at a desired site withinthe patient's body with the tissue penetrating distal tip of the outercannula disposed distal to the tissue specimen to be separated from thetarget site. A vacuum is established within the inner lumen of thetubular section to draw tissue through the aperture therein into theinner lumen of the tubular section. The cutting member, which isslidable disposed within the inner lumen of the tubular section, maythen be moved longitudinally to cut a tissue specimen from supportingtissue at the target site by the longitudinal motion, which preferablyincludes oscillating rotational movement and/or reciprocatinglongitudinal movement. The vacuum established within the inner lumen ofthe tubular section may be applied through the inner lumen of the tissuecutting member when the tissue cutting member is disposed within thetubular section. The applied vacuum within the inner lumen of the tissuecutting member, may also be utilized to pull or aspirate the separatedtissue sample proximally. In addition, or alternatively, a higher fluidpressure may be maintained in a distal part of the inner lumen of thetubular section, distal to the specimen, to push the tissue specimenproximally, Alternatively, the tissue specimen may be mechanicallywithdrawn. Fluid pressure may include pressure from a liquid deliveredinto the interior of the device, such as a physiological salinesolution, and may include a gas, such as pressurized carbon dioxide,nitrogen or air, delivered into the interior of the device. Access toambient air can also maintain a sufficiently high pressure differentialto move the specimen through the inner lumen of the cutting member.Anesthetic may be injected to the target site through the outer cannulaor the inner lumen of the cutting member. Upon removal from the patient,the tissue specimen may then be subjected to pathological examination.After acquisition of a tissue specimen or specimens, the tissueseparation system may be repositioned for further tissue separation andcollection or it may be withdrawn from the patient.

The tubular section of the probe provides the support for the probe toenable precise location of the accessing port to the desired location atthe target site with its radial orientations being preset before thedevice is introduced into the patient or selected after the tubularsection is disposed within the patient. The cutting member quickly andcleanly severs the tissue specimen drawn into the interior of thetubular section though the aperture by the action of the vacuum orotherwise. Upon removal of the tissue specimen, the tissue receivingaperture may be radially repositioned about the longitudinal axis of thetubular section of the probe component so that a plurality of specimensmay be taken from the target site. The orientation of the tissuereceiving aperture during the procedure may follow a preselected patternor may be selected by the physician for other selected tissue specimens.

A tissue acquisition system assembly embodying features of the inventionmay include a device for delivery of one or more marker bodies through atubular member of a biopsy device such as the tubular cutting member.Such a marker delivery device includes an elongated shaft having aninner lumen and a discharge opening in a distal portion of the elongatedshaft, at least one marker body which is disposed within the inner lumenof the elongated shaft, a pusher element which is slidably disposedwithin the delivery device and which is configured to urge at least onemarker body out the discharge opening in the distal portion of theelongated shaft. The marker delivery device has a distally flared guidemember which is slidably disposed on the elongated shaft to guide thedistal portion of the elongated shaft into a proximal end of the tubularmember of a biopsy device. This invention is directed to a tissuepenetrating probe tip, particularly for biopsy devices. These devicesprovide access to a targeted tissue site and provide for the separationand capture of a tissue specimen from supporting tissue at the targetedsite.

These and other advantages of the invention will become more apparentfrom the following detailed description of the invention and theaccompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of the elongated tissue biopsy systemembodying features of the invention.

FIG. 2 is a perspective view of the embodiment shown in FIG. 1 in anassembled condition without a housing cover for the probe component.

FIG. 3 is a side elevational view of the tissue biopsy device shown inthe FIG. 2.

FIG. 4A is a longitudinal cross-section of the probe shown in FIG. 3taken along the lines 4-4 with the tissue cutting element in a withdrawnposition.

FIG. 4B is a longitudinal cross-section of the probe shown in FIG. 3taken along the lines 4-4 with the tissue cutting element in a forwardor closed position.

FIG. 5 is a transverse cross-sectional view of the probe shown in FIG.4B taken along the lines 5-5.

FIG. 6 is a perspective view of the underside of the probe shown in FIG.1.

FIG. 7 is an enlarged perspective view of the distal end of the driverunit shown in FIG. 1.

FIG. 8 is an enlarged perspective view of the distal end of the probehousing illustrating a marker element which depicts the orientation ofthe aperture in the tubular section of the biopsy device.

FIG. 9 is a perspective view of the underside of the driver shown inFIG. 1.

FIG. 10 is an elevational view of a tissue penetrating tip embodyingfeatures of the invention.

FIG. 11 is a perspective view of the underside of the tip shown in FIG.10.

FIG. 12 is a longitudinal, center line cross-sectional view of thepenetrating tip shown in FIG. 10.

FIG. 13 is a longitudinal cross-sectional view of the penetrating tipshown in FIG. 12 taken along the lines 13-13.

FIG. 14 is a longitudinal cross-sectional view of the penetrating tipshown in FIG. 12 taken along the lines 14-14.

FIG. 15 is a longitudinal cross-sectional view of the penetrating tipshown in FIG. 3 taken along the lines 15-15.

FIG. 16 is a bottom view of the penetrating tip shown in FIG. 10.

FIG. 17 is a transverse cross-sectional view of the penetrating tipshown in FIG. 16 taken along the lines 17-17.

FIG. 18 is a transverse cross-sectional view of the penetrating tipshown in FIG. 16 taken along the lines 18-18.

FIG. 19 is a transverse cross-sectional view of the penetrating tipshown in FIG. 16 taken along the lines 19-19.

FIG. 20 is a transverse cross-sectional view of the penetrating tipshown in FIG. 16 taken along the lines 20-20.

FIG. 21 is a perspective view of the tissue biopsy system shown in FIG.1 assembled and mounted on a stereotactic frame.

FIG. 22 is an elevational view of a marker delivery device with a flaredguide on the distal end of the shaft which facilitates guiding thedistal tip of a marker delivery device into the interior of the proximalend of the tissue cutter.

FIG. 23 is a longitudinal cross-sectional view of the distal end of themarker delivery device and flared guide disposed within the tissuecollection component shown in FIG. 1.

FIG. 24 is a longitudinal cross sectional view of the proximal end ofthe marker delivery device with the flared guide at the proximal end ofthe shaft and with the shaft deployed within the inner lumen of thetissue cutter.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

FIGS. 1-3 illustrate a biopsy system 10 embodying features of theinvention which includes a disposable probe component 11, a drivercomponent 12 and specimen collector 13.

The probe component 11 generally includes an elongated distal shaft 14having a tubular section or cannula 15 with a tissue penetrating tip 16on the distal end thereof and an open, tissue receiving aperture 17. Theprobe component 11 also includes a probe housing 18 with a housing cover19 which is configured to interfit with the driver component 12. Atissue cutter 20 is slidably disposed within the probe and has a distalcutting surface 21 which severs tissue which extends through the tissuereceiving aperture 17.

Details of the probe component 11 are further shown in FIGS. 4A and 4B.The probe housing 18 has a mechanical system for rotating the housingand the tubular section 15 secured thereto to control the angularposition of the tissue receiving aperture 17 and for moving the tissuecutter 20 slidably disposed within the probe component 11.

The mechanical system of the driver component 12 has first driving gear22 that is configured to engage the probe gear 23 and rotate the probehousing 18 so as to adjust the orientation of aperture 17 in the distalextremity of the tubular section 15. The probe gear 23 is secured to therotating connector body 24 by adhesive 25. The proximal extremity of thetubular section 15 is secured to the rotating connector body 24 byadhesive 26. An end cap 27 retains the connector body 24 within theprobe housing 18. Rotation of the probe gear 23 rotates the connectorbody 24 and the attached tubular section 15. The rotation is preferablycontrolled so that the tubular section 15 rotates in discrete stepsabout the longitudinal axis 28 to adjust the angular orientation of theaperture 17 about the longitudinal axis. Preferably these discreteorientations may be provided in increments of 30° which can be readilyindicated by arrow 29 at the distal end of the probe housing 18 as shownin FIG. 8.

The second driving gear 30 is configured to drive the tissue cutter 20longitudinally. The driving gear 30 engages probe gear 31 which drivescutter traverse nut 32 and cutter screw 33 threadably connected to thecutter traverse nut. The distal end of the cutter screw 33 is providedwith a recess 34 which receives the rib 35 of the cutter shuttle 36. Thecutter shuttle 36 is secured to the tissue cutter 20 by adhesive 37. Theprobe gear 31 is secured to the cutter traverse nut 32 by adhesive 38.Rotation of the probe gear 31 adjusts the relative axial position of thecutter screw 33 with respect to the cutter traverse nut 32 which issecured to the cutter shuttle 36. Longitudinal movement of the tissuecutter 20 follows the longitudinal movement of the cutter shuttle 36resulting from the movement of cutter screw 33. The length of the tissuereceiving aperture 17, and as a result the length of the specimen, canbe controlled by adjusting the initial longitudinal position of thedistal end of the tissue cutter 20 within the aperture, before cutting.

The third driving gear 40 is configured to rotate or oscillate thetissue cutter 20 as the cutter moves along the longitudinal axis 28 tofacilitate the cutting action of the cutting surface 21 on the distalend of the cutter. The third driving gear 40 engages probe gear 41 whichis secured to cutter oscillation shaft 42 by adhesive 43. The probe gear41 may be oscillated back and forth about the longitudinal axis 28 orrotated continuously in a single direction about the longitudinal axis,or both depending upon the desired rotational movement of the tissuecutter.

A biased valve assembly 44 is provided in the distal end of the probehousing 18 to ensure sealing when a vacuum is developed within theinterior 45 of the tissue cutter 20 while providing an atmospheric vent46 between the interior surface 47 of the tubular section 15 and theexterior surface 48 of the tissue cutter 20. The valve assembly 44includes a spring 49, valve body 50 and a valve collar 51 which issecured to the proximal end of the tubular section 15 by adhesive 52.The proximal end of the valve spring 49 rests against the shoulder 53provided in the exterior of the valve body 50. A biased cutter shaftseal 54 slidably engages the exterior 48 of the tissue cutter 20.

The tissue specimen collector 13 is secured to the proximal end of thehousing of probe component 11 and has an interior 55 in fluidcommunication with the inner lumen 56 extending within the tissue cutter20 and has a removable proximal wall 57 of specimen receiving cartridge58 which gives access to the interior 55 and any tissue specimens whichmay have been drawn therein. A vacuum is generated within the interior55 to draw tissue specimens through the inner lumen 45 into the interior55. Tubular member 59 has a distal end which is in fluid communicationwith the interior 55 of the tissue specimen collector 13 and has aproximal end (not shown) which is configured to be connected to a vacuumsource. Application of a vacuum within the tubular member 59 aids inpulling tissue into the interior 17 of the tubular section 15 andtransfer of the severed tissue specimen through the inner lumen 45 ofthe tissue cutter 20 to the specimen cartridge 58.

The driver 12 has a housing 60 with an upper concave surface 61 which isconfigured to receive the lower surface 62 of the probe housing 18.Three partially exposed driving gears 22, 30 and 40 are provided on theproximal end of the driver 12 which are configured to engage the probegears 23, 31 and 41 respectively. The drive 12 is provided with threeseparately operating drive motors (not shown) which drive the drivegears 22, 30 and 40. The separate drive motors (not shown) are connectedto and the operation thereof controlled by a control module, such asdescribed in copending application Ser. No. 10/847,699, filed on May 17,2004. The control module controls the motors which move the individualdrive gears 22, 30 and 40. The gear 22 engages gear 23 in the probe 11to control the rotation of the probe housing 18 and the location andorientation of the tissue receiving aperture 17. The drive gear 30engages probe gear 31 to control the longitudinal position and motion ofthe tissue cutter 20 along the longitudinal axis 28. Drive gear 40engages probe gear 41 to control the oscillation or rotation of thetissue cutter 20 about the longitudinal axis 28.

As shown in FIG. 7, the front face of the driver component 12 isprovided with light sources 66 and 67 and a manually activatable switch68 to activate the light sources and enable the physician and otheroperating personnel to better view the operating site on the patient.Other manual switches, e.g. a foot activated switch, may be employed.Alternatively, the light sources may be automatically activated when theprobe component 11 is installed on the driver 12 or other events such aswhen electrical power is turned on. The driver component 12 may have abattery pack for the light sources 66 and 67.

The tissue penetrating distal tip 16 may have a variety of tip shapes. Aparticularly suitable distal tip embodying features of the invention isshown in FIGS. 9-20. The tissue penetrating distal tip generallyincludes a base 70, a sharp distal point 71, a first concave surface 72,a second concave surface 73 and a third concave surface 74.

The intersection between the first concave surface 72 and the secondconcave surface 73 forms the first curved cutting edge 75. Theintersection between the second concave surface 73 and the third concavesurface 74 forms the second curved cutting edge 76. The intersectionbetween the third concave surface and the first concave surface 72 formsthe third curved cutting surface 77.

The concave surfaces 72, 73 and 74 are hollow ground and the pentratingtip 16 is then electro-polished to increase the sharpness of the cuttingedges 75, 76 and 77. The penetrating distal tip 16 may be formed ofsuitable surgical stainless steel such as 17-4 stainless steel. Othermaterials may be suitable. The penetrating distal tip 16 is preferablyelectro-polished in an acidic solution to sharpen the curved cuttingedges and thereby facilitate tissue penetration. Suitableelectro-polishing solutions include Electro Glo sold by the Electro GloDistributing Co.

The base 70 of the tissue penetrating tip 16 may be secured to thedistal end of the elongated shaft of the biopsy device 10 for accessingand collecting tissue from a target site within a patient. The sharpdistal tip 16 embodying features of the invention readily penetrates apatient's tissue, particularly breast tissue and facilitates guiding thedistal end of the biopsy or other device to a desired intracorporeallocation.

The tissue penetrating tips may also be employed on biopsy devices suchas those described in co-pending application Ser. No. 10/642,406, filedon Aug. 15, 2003, which is assigned to the present assignee.Alternatively, the distal tip may be provided with an arcuate RFelectrode such as disclosed in U.S. Pat. Nos. 6,261,241, and 6,471,700,both assigned to the present assignee.

The separate driver component 12 allows the probe unit 11 to bedisposable. The drive gears of the drive component 12 control the motionof the tissue cutting member 20 for cutting and the motion of thetubular section 15 to orient the aperture 17. Other means (not shown)may provide mechanical and electrical power, vacuum, and control to theprobe device. Examples of replaceable snap-in type probe units aredisclosed in Burbank et al., U.S. patent application Ser. No.10/179,933, “Apparatus and Methods for Accessing a Body Site”. Driveunits such as that described in WO 02/069808 (which corresponds toco-pending U.S. application Ser. No. 09/707,022, filed Nov. 6, 2000 andU.S. application Ser. No. 09/864,021, filed May 23, 2001), which areassigned to the present assignee, may be readily modified by thoseskilled in the art to accommodate the movement of the cutting member 20.

In use, the distal end of the probe component 11 is advanced within thepatient with the tissue cutter 20 in a forward or closed position (FIG.4B), until the aperture 17 of the tubular section 15 is located in adesired location for taking a tissue specimen. The tissue cutter 20 isthen withdrawn proximally to an open position to open the aperture 17.The withdrawal of the tissue cutter can be used to control the length ofthe aperture which is opened in order to control the length of thespecimen which is severed. A vacuum is applied to the interior 45 of thetissue cutter 20 to draw tissue at the site into the inner lumen of thetubular section 15 through the aperture 17. The tissue cutter 20 is thendriven distally by rotation of probe gear 30 and rotated or oscillatedby drive gear 40 engaging probe gear 41 to sever the aspirated tissuefrom the supporting tissue at the target site with the tissue cuttingsurface 21. The vacuum within the interior of the tissue cutter 20causes the tissue specimen to be drawn through the inner lumen 45 of thetissue cutter 20 and into the cartridge 58 of specimen collector 13shown in FIG. 2. Positive pressure or even ambient conditions distal tothe tissue specimen can facilitate tissue passing through the interior45 of tissue cutter 20. If another tissue specimen is desired, thetubular section 15 may be rotated by the drive gear 22 engaging theprobe gear 23 in one or more steps to repeat obtaining another tissuespecimen in the same manner without otherwise moving the probe component11. Typically, a first tissue specimen is obtained with the aperture 17of the probe 11 in the 12 o-clock position, the second at the 3 o-clockposition, the third at the 9 o-clock position and the fourth at the 6o-clock position. The location of the second and third specimens may bereversed. The position of the aperture 17 may be indicated by a markerarrow 29 at the end cap 27 so that the physician or other operatingpersonnel can readily determine what the orientation of the aperture 17within the patient.

The biopsy system 10 may be hand held for some biopsy procedures or thesystem may be mounted on a stereotactic mounting stage 80 as shown inFIG. 21. A shoe 81 is slidably mounted to a rail 82 of a Fisher stage.The mounting member 83 is secured to the shoe 81 by a threaded post (notshown) secured to thumbwheel 84. As shown in FIG. 10, the bottom surface85 of the driver component 12 is configured to conform at least in partto the upper surface of the mounting member 83. The sampling and vacuumswitches 86 and 87 respectively on the driver component 12 are actuatedby the optional sampling and vacuum actuating elements 88 and 89 on themounting member 83. Alternatively, sampling and vacuum may be actuatedwith a foot pedal. As shown in FIG. 22, the driver component has anoperator dial 90 which when turned opens a threaded hole 91 forreceiving a threaded post (not shown) secured to the thumbwheel 84 andthe locating pin holes 92 and 93 which receive the complementary posts(not shown) in the mounting member 83.

As mentioned above, positive pressure or even ambient conditions willaid in passing the severed tissue specimen through the inner lumen 45 oftissue cutter 20 into the cartridge 58 of specimen collector 13. Asshown in FIGS. 4A and 4B venting valve can provide ambient pressurebehind the tissue specimen in the cutter interior 45 from the interiorof the tubular section 15. The valve body 50 is opened for atmosphericventing when the tissue cutter 20 is in the forward position upon thecompletion of severing the specimen from the tissue site. However, whenthe tissue cutter 20 is pulled back proximally the valve spring 49 urgesthe valve body 50 back to a closed position. While the tissue cutter 20is shown with a tissue cutting surface 21 which is perpendicular to thelongitudinal axis 28, the tissue cutting surface may be at an angle oreven parallel to the longitudinal axis as described in co-pendingapplication Ser. No. 10/642,406, filed Aug. 15, 2003.

The distal cutting edge 21 of the tissue cutter 20 may initially belocated proximal to the aperture 17 to provide a full aperture forreceiving tissue or it can be initially located within the aperture 17in order to control the length of the specimen. The cutting action oftissue cutter 20 preferably continues until the beveled cutting surface21 has completely traversed the aperture 17 to ensure that the tissuedrawn through the aperture is completely severed from supporting tissueat the biopsy site. A vacuum may be applied to aspirate the severedtissue specimen through the inner lumen of the tissue cutter 20 to thecartridge in the specimen collector at the proximal end of the biopsydevice. Positive pressure or access to ambient conditions may beprovided in the distal end of the tubular section to aid in the specimentransfer.

After the removable wall 57 of the specimen receiving cartridge 58 isremoved and the specimens therein removed, it is frequently desirable todeliver one or more markers to the target site from which the specimenshave been removed. Such marker delivery devices are shown in co-pendingapplication Ser. No. 10/753,694, filed on Jan. 7, 2004 and co-pendingapplication Ser. No. 10/444,770, filed May 23, 2003. However, the distalends of these marker delivery devices are very small and they can bedifficult to insert into the proximal end of the tissue cutter 20 whichis just slightly larger to accommodate the marker delivery shaft.

FIG. 22 illustrates a marker delivery device 100 which is particularlysuitable to facilitate the introduction of the distal end of the shaft101 into the inner lumen 45 of the tissue cutter 20 and the advancementtherein. As shown in FIG. 23, to facilitate the insertion of the smalldiameter distal tip 101 of the marker delivery device 100 into theslightly larger inner lumen 45 of the tubular cutter 20 at its proximalend, the distal tip is preferably provided with an outwardly flaredguide 102 which is slidably mounted on the shaft 103 of the markerdelivery device 100. The proximal end of the tubular cutter 20, theflared guide 102 and/or the distal tip 101 may be provided with matingguide elements which orient the marker delivery device with the cannula15 of the biopsy device. To ensure that one or more markers aredischarged through the aperture 17 of the biopsy device 10 when thepusher element slidably disposed within the delivery device is urgeddistally to press at least one marker body out the discharge opening inthe distal portion of the elongated shaft of the marker delivery device.As indicated in FIG. 23, the shaft 103 of the marker delivery device 100is advanced into the inner lumen 45 of the tissue cutter 20 so that thedistal end 101 of the marker delivery device 100 is adjacent to theaperture 17 of the cannula 15. Plunger 104 is pressed further into theinner lumen of shaft 103 to eject one or more markers 105 through theaperture 17 in the tubular section 15 before the biopsy device 10 isremoved from the patient. The delivery of markers to the target siteafter specimen removal, while the distal end of the biopsy device isstill at the biopsy site, ensures that the markers are properly positionat the biopsy site.

While the slidably mounted, flared proximal guide 102 is described withrespect to being disposed on the shaft 103 of marker delivery device101, the flared guide 102 has wide application within a variety ofbiopsy and other devices where one small diameter tubular member is tobe inserted into a slightly larger, but still small diameter secondtubular member.

The elongated probe component 11 of the biopsy system 10 has a length ofabout 3 to about 20 cm, preferably, about 5 to about 13 cm, and morespecifically, about 8 to about 9 cm for breast biopsy use. To assist inproperly locating the probe 11 during advancement thereof into apatient's body, the distal extremity of the tubular section may beprovided with a marker at a desirable location that provide enhancedvisualization by eye, by ultrasound, by X-ray, MRI or other imaging orvisualization means. Manual palpation may also be employed. An echogenicpolymer coating that increases contrast resolution in ultrasound imagingdevices (such as ECHOCOA™ by STS Biopolymers, of Henrietta, N.Y.) issuitable for ultrasonic visualization. Radiopaque markers may be madewith, for example, stainless steel, platinum, gold, iridium, tantalum,tungsten, silver, rhodium, nickel, bismuth, other radiopaque metals,alloys and oxides of these metals. In addition, the surfaces of thedevice in contact with tissue or other components of the device may beprovided with a suitable lubricious coating such as a hydrophilicmaterial or a fluoropolymer.

The tubular section and the tissue cutter are preferably formed of asurgical grade stainless steel. However, other high strength materialssuch as MP35N, other cobalt-chromium alloys, NiTi alloys, ceramics,glasses, and high strength polymeric materials or combinations thereofmay be suitable.

A patient's skin usually must be breached in order to gain access to abody site where a tissue specimen is to be obtained. A scalpel or othersurgical instrument may be used to make an initial incision in the skin.After the specimens have been taken, the biopsy device may be removedfrom the patient. The entire device may be removed; however, in someembodiments, the cartridge 58 may be removed from the system 10 and adelivery cannula may be inserted through the inner lumen of the cutter20 to deliver markers to the biopsy site through the aperture 17. Inaddition, it will be readily appreciated that other types of instrumentsmay be inserted into the tissue site through the tissue cutter inaddition to or in place of the instruments described above. Moreover,therapeutic or diagnostic agents may be delivered through the tissuecutter 20 or the tubular section 15.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. For example, while thevarious embodiments of the invention have been described herein in termsof a biopsy device, it should be apparent that the devices and methodsof utilizing the device may be employed to remove tissue for purposesother than for biopsy, i.e. for treatment or other diagnoses.Additionally, the tissue penetrating distal tip design may be employedon probes for other uses. Other modifications include, for example, atissue cutter slidably mounted around the tubular section of the probecomponent rather than within the tubular section. Moreover, individualfeatures of embodiments of the invention may be shown in some drawingsand not in others, but those skilled in the art will recognize thatindividual features of one embodiment of the invention can be combinedwith any or all the features of another embodiment. Accordingly, it isnot intended that the invention be limited to the specific embodimentsillustrated.

Terms such a “element”, “member”, “device”, “section”, “portion”,“means”, “step” and words of similar import, when used in the followingclaims, shall not be construed as invoking the provisions of 35 U.S.C.§112(6) unless the claims expressly use the term “means” followed by aparticular function without specific structure or the term “step” or“steps” followed by a particular function without specific action. Allpatents and patent applications referred herein are incorporated byreference in their entirety.

1. A method for collecting one or more tissue specimens from a targetsite within a patient and delivering at least one marker body to thetarget site, comprising: a. providing a biopsy device having: i. adisposable elongated probe component comprising an elongated tubularsection which has a central longitudinal axis, which has an inner lumenextending therein, which has a penetrating distal tip with a sharpdistal point that is centrally located to lie on the centrallongitudinal axis and a base proximal to the sharp distal point andthree intersecting surfaces including a first concave surface, a secondconcave surface which intersects the first concave surface formingtherewith a first continuous curved tissue cutting edge that extendsfrom the base to the sharp distal point and that lies in a first planethat is parallel to and passes through the central longitudinal axis,and a third concave surface which intersects the first concave surfaceforming therewith a second continuous curved tissue cutting edge thatextends from the base to the sharp distal point and that lies in asecond plane that is parallel to and passes through the centrallongitudinal axis and which intersects the second concave surfaceforming therewith a third continuous curved tissue cutting edge thatextends from the base to the sharp distal point and that lies in a thirdplane that is parallel to and passes through the central longitudinalaxis, the tubular section having an aperture proximal to the penetratingdistal tip configured to receive tissue from the target site, and ii. anelongated tubular tissue cutting member which is disposed within theelongated tubular section, which has at least one tissue cutting edgefor removal of tissue extending through the aperture in the tubularsection, which has an inner lumen extending therein and which isdisposed within the tubular tissue cutting member with the cutting edgedistal to the aperture opening so as to close the opening; and iii. adriver component which is configured to receive a proximal portion ofthe probe component in an operational relationship, which has a firstdriver motor configured to rotate the tubular section of the probecomponent to orient the tissue receiving aperture in the distal end ofthe tubular section and which has a second driver motor configured todrive the tissue cutting member longitudinally within the tubularsection to cut a tissue specimen from tissue extending into the tissuereceiving aperture of the elongated tubular member; b. advancing theprobe component into and through soft tissue wherein each of the firstcontinuous curved tissue cutting edge, the second continuous curvedtissue cutting edge, and the third continuous curved tissue cutting edgecut the soft tissue to aid the advancing, the probe component beingadvanced until the tissue penetrating tip is located distal to thetarget site with the tissue receiving aperture closed by the tissuecutter; c. withdrawing the tissue cutter proximally to open a desiredlength of the tissue receiving aperture; d. applying a vacuum within thetubular section to draw tissue at the tissue site through the tissuereceiving aperture of the tubular section into the interior thereof; e.advancing the tissue cutting member distally within the tubular sectionof the probe member to cut a tissue specimen from the tissue extendinginto the tubular section with the tissue cutting edge of the tissuecutting member; and f. transporting a cut tissue specimen through theinner lumen of the tissue cutting member and out a discharge opening inthe proximal end thereof.
 2. A method of accessing a desirableintracorporeal site within soft tissue of a patient, comprising: a.providing a elongated probe having a central longitudinal axis and atissue penetrating distal tip, the tip having i. a sharp distal pointthat is centrally located to lie on the central longitudinal axis, ii. aproximal base, and iii. three intersecting curved surfaces including afirst concave surface, a second concave surface which intersects thefirst concave surface forming therewith a first continuous curved tissuecutting edge that extends from the base to the sharp distal point andthat lies in a first plane that is parallel to and passes through thecentral longitudinal axis, and a third concave surface which intersectsthe first concave surface forming therewith a second continuous curvedtissue cutting edge that extends from the base to the sharp distal pointand that lies in a second plane that is parallel to and passes throughthe central longitudinal axis and which intersects the second concavesurface forming therewith a third continuous curved tissue cutting edgethat extends from the base to the sharp distal point and that lies in athird plane that is parallel to and passes through the centrallongitudinal axis; and b. advancing the probe through the patient's softtissue wherein each of the first continuous curved tissue cutting edge,the second continuous curved tissue cutting edge, and the thirdcontinuous curved tissue cutting edge cut the soft tissue to aid in theadvancing, the probe component being advanced until the tissuepenetrating tip is distal to the desired intracorporeal location.
 3. Themethod of claim 1 wherein the tubular section of the probe component isrotated about its longitudinal axis to provide a desired orientation tothe tissue receiving aperture.
 4. The method of claim 1 wherein thelongitudinal motion of the tissue cutting member includes oscillationmotion to provide scissor-like tissue cutting.
 5. The method of claim 1wherein the tubular section is rotated about its longitudinal axis indiscrete rotational increments.
 6. The method of claim 5 wherein thediscrete rotational increments are about 15° to about 45°.
 7. The methodof claim 5 wherein the discrete rotational increments are about 90°.